Age | Body mass index
Item
male or female patients aged 40 to 80 years with bmi < 30 kg/m²
boolean
C0001779 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Kellgren-Lawrence score | Knee Osteoarthritis Primary Symptomatic | Indication Therapeutic procedure Intraarticular
Item
patient with kellgren-lawrence grade 2 to 3, symptomatic primary osteoarthritis at the index knee (acr criteria), for which an ia treatment is indicated
boolean
C3177117 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0442108 (UMLS CUI [3,3])
Pain intensity Moderate | Pain intensity Severe | NSAIDs Dose chronic
Item
pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
boolean
C1320357 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1320357 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Drug Allergy | Allergy to acetaminophen | Hypersensitivity Disinfectants
Item
history of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
boolean
C0013182 (UMLS CUI [1])
C0570513 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0012682 (UMLS CUI [3,2])
Pharmacotherapy Comorbidity
Item
any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
boolean
C0013216 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
CORTICOSTEROIDS FOR SYSTEMIC USE U/day | Topical corticosteroids U/day | Prednisolone Equivalent U/day | Immunosuppressive Agents
Item
use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
boolean
C3653708 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0304604 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C0021081 (UMLS CUI [4])
Analgesics | Pharmaceutical Preparations Osteoarthritis | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Antidepressive Agents | Treatment Topical
Item
current use of any pain or oa medication (e.g. nsaids, cox-2 inhibitors, analgesics, antidepressive agents), including topical treatments
boolean
C0002771 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3])
C1257954 (UMLS CUI [4])
C0003289 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C1522168 (UMLS CUI [6,2])
Viscosupplementation Target Knee
Item
viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
boolean
C2350507 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Liver disease | Renal Insufficiency Moderate | Renal Insufficiency Severe
Item
evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
boolean
C0023895 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
CYP3A4 Substrate | CYP3A4 Inhibitor Moderate | CYP3A4 Inhibitor Strong
Item
current use of any medications that are substrate of cyp3a4 and/or moderate or strong cyp3a4 inhibitors
boolean
C3714798 (UMLS CUI [1,1])
C3891814 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3830624 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
Disease At risk Patient | Malignant Neoplasms At risk Patient | Disease Interferes with Research results | Malignant Neoplasm Interferes with Research results
Item
patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Laboratory test result abnormal | Abnormal vital signs | ECG abnormal
Item
patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ecg parameters
boolean
C0438215 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant and breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Signs Immunodeficiency | Signs Sepsis | Signs Knee infection | Signs Knee bursitis
Item
any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
boolean
C0311392 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0243026 (UMLS CUI [2,2])
C0311392 (UMLS CUI [3,1])
C1400580 (UMLS CUI [3,2])
C0311392 (UMLS CUI [4,1])
C0410092 (UMLS CUI [4,2])
Bleeding tendency | Anticoagulant therapy
Item
patients with bleeding diathesis or on therapy with anticoagulants
boolean
C1458140 (UMLS CUI [1])
C0150457 (UMLS CUI [2])